On November 30, 2012, the U.S. Supreme Court granted certiorari
in Association of Molecular Pathology, et al. v. Myriad
Genetics, Inc., et al. (No. 12-398), with the grant limited to
petitioners' first of three questions: "Are human genes
patentable?" The Court denied the petitioners' request to
determine whether the U.S. Court of Appeals for the Federal Circuit
erred in upholding a method claim directed to screening potential
cancer therapeutics via changes in cell growth rates, which
petitioners argued was irreconcilable with the Court's ruling
in Mayo Collaborative Servs. v. Prometheus Labs., Inc.,
132 S. Ct. 1289 (2012). In addition, the Court declined to address
the Federal Circuit's holding requiring a plaintiff to first be
threatened with an infringement action in order to gain standing to
challenge the asserted patents.
The Supreme Court has granted certiorari on several cases in
recent years concerning the patentability of methods. Mayo
Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct.
1289 (2012); Bilski v. Kappos, 130 S. Ct. 3218 (2010);
see also Lab. Corp. of Am. Holdings v. Metabolite Labs., Inc.,
cert. dismissed, 548 U.S. 124 (2006). The Court, however, has
not addressed the question of Section 101 patent eligibility of
compositions of matter for over 30 years. Diamond v.
Chakrabarty, 447 U.S. 303 (1980).
In a 2-1 decision on August 16, the Federal Circuit upheld
Myriad's right to patent "isolated" genes linked to
an increased risk of breast and ovarian cancer and methods for
screening potential cancer therapeutics. Calling the process of
removing DNA from the human body "the product of human
ingenuity," the majority came to its decision upon determining
that genomic and isolated DNA possess markedly different chemical
properties. The Federal Circuit, however, concluded that
Myriad's claims comparing or analyzing gene sequences are
directed to an abstract mental process and, therefore, are
indistinguishable from the claims the Supreme Court held
unpatentable in Mayo.
A variety of medical associations and doctors, led by the
Association for Molecular Pathology and the American Civil
Liberties Union, is now appealing the Federal Circuit's ruling
on the ground that isolated gene sequences, and the diagnostic
methods of identifying mutations in those sequences, involve
products of nature and thus are ineligible subject matter for
patenting.
What This Means for You
It remains to be seen whether the Court will consider this case to be controlled by its March ruling in Mayo, which held that a method involving a correlation that exists in nature could not be patented. The Court's decision in this case will be closely followed as it could reshape medical research regarding "isolated" genes in the U.S., and potentially impact the fight against diseases like breast cancer, in which genetic testing is a diagnostic option.
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